Related Experiment Video
Updated: Jul 10, 2025

Utilizing Percutaneous Ventricular Assist Devices in Acute Myocardial Infarction Complicated by Cardiogenic Shock
Published on: June 12, 2021
Adverse events with intravascular lithotripsy after coronary use: A report from the FDA MAUDE database
Athanasios Rempakos1, Bahadir Simsek1, Spyridon Kostantinis1
1Minneapolis Heart Institute and Minneapolis Heart Institute Foundation, Abbott Northwestern Hospital, Minneapolis, Minnesota, USA.
Abstract:
Percutaneous coronary intervention (PCI) on heavily calcified lesions has been associated with more complications.1 Intravascular lithotripsy (IVL) was recently approved for treating de novo calcified coronary lesions based on excellent safety and efficacy on several studies, but there are limited "real world" outcomes. We conducted a comprehensive search of the MAUDE database between February 12, 2021, and February 28, 2023 using the manufacturer and brand name tabs with the keywords "Shockwave Medical" and "Shockwave," respectively. Given that a single IVL catheter can fail or cause multiple adverse events through different mechanisms, we considered all possible outcomes. The MAUDE database is freely accessible and de-identified, obviating the need for institutional review board approval.
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